Today, the Food and Drug Administration (FDA) proposed to clear away unnecessary roadblocks to the approval of generic drug products. I am encouraged by the FDA's important action to address the competitive problems existing in the approval process for generic drug products.

The Federal Trade Commission's recently released report, Generic Drug Entry Prior to Patent Expiration, described a new industry practice that delays FDA approval of generic drug products. This practice entails brand-name pharmaceutical companies using questionable methods to obtain multiple 30-month stays of FDA approval of generic drugs. Our report documented that since 1998, brand-name companies have obtained multiple 30-month stays of generic applications for six brand-name drug products. The FDA's proposal, if promulgated and upheld, will be an effective way to bring the economic benefits of generic drugs to consumers more quickly.

The FDA also proposes to amend the requirements for listing patents in the Orange Book. This proposal, if promulgated and upheld, is another important step to reduce the problems the FTC identified with patent listings. Although FDA's proposal does not incorporate all of the FTC's suggestions to clarify Orange Book listings, I look forward to working with the FDA to ensure that improper Orange Book listings do not reduce competition in the pharmaceutical industry.

Contact Information

Media Contact:

Cathy MacFarlaneOffice of Public Affairs
202-326-3657

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